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NCT07742735PHASE3Recruiting

A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)

VectivBio AG

Start Date

8/1/2026

Completion Date

10/1/2029

Summary

This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.

Detailed Description

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy, safety, and tolerability of apraglutide compared with placebo in adults with SBS-IF. The study population will be representative of the SBS-IF general population and will include adult participants (≥18 years of age) who are dependent on, and who are receiving, PS at least 3 days per week. Eligible participants will be randomized 1:1 to receive SC apraglutide or placebo once weekly for 24 weeks stratified by anatomy (i.e., colon-in-continuity \[CIC\] or stoma) and baseline parenteral support (PS) volume (i.e., \<12 L/week or ≥12 L/week). The number of randomized participants in CIC and stoma will be monitored to ensure approximately equal numbers of CIC and stoma participants are randomized. The study will consist of 4 periods: a Screening Period prior to randomization (including optimization and stabilization phases), a Treatment Period starting at randomization, a Safety Follow-up (SFU) Period after the last dose of IMP is completed, and an Anti-Drug Antibody (ADA) Follow-up Period beginning after the last dose of IMP. All participants who complete the IMP treatment will be offered participation in an open label single arm apraglutide long-term extension (LTE) study. Participants who do not wish to continue onto the LTE study will be requested to complete an SFU Visit, which will occur 4 weeks (±1 week) after the last dose of IMP, after which they will transition into ADA Follow-Up period.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participant must be ≥18 years of age, at the time of signing the informed consent. * Male and female participants with SBS-IF, receiving PS secondary to surgical resection of the small intestine with residual length ≥10 cm to \<200 cm from duodeno-jejunal flexure, based on available clinical and/or medical/surgical records, and with either: (a.) CIC remaining and neither jejunostomy nor ileostomy with the latest intestinal resection resulting in SBS-IF being at least 12 months prior to Screening OR (b.) Jejunostomy or ileostomy with the latest intestinal resection resulting in SBS-IF being at least 6 months prior to Screening. * BMI of ≥18.5 to \<30 kg/m2 at randomization. * Individuals of any gender identity, assigned male or female at birth are eligible to participate. Male participants: Male participants with a female partner of childbearing potential must commit to practice highly effective methods of contraception (eg, condom, vasectomy) and abstain from sperm donation during the study and for 2 weeks after the EOT/Early Discontinuation (ED) Visit. Female participants: Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the study and for 4 weeks after the EOT/ED Visit. To be considered sterilized or infertile, female participants must have undergone surgical sterilization (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause; a follicle-stimulating hormone \[FSH\] test \[with or without estradiol\] is required to confirm if there is doubt). Women who do not engage in heterosexual intercourse will be allowed to join the study without contraception following a thorough discussion with the investigator to determine if this is feasible for the participant. The following are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, postovulation methods, withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method. * Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. * PS requirement of at least 3 days per week as assessed before Screening, at the end of optimization, and at the time of randomization. * Participant is considered optimized (average drinking volume is ≥1.0 L and ≤3.5 L per day and the average urinary volume is ≥0.8 L and ≤2.5 L per day) at study Visit 2a, 2b, or 2c. * Participant is considered stable with regard to PS volume requirement, drinking volume, and urinary output at last Stabilization Phase Visit and Visit 4 when the actual PS usage matches prescribed PS (±10% deviation in volume from the last optimization visit), average urine volume at the last stabilization visit and randomization visit match (±25% deviation from last optimization visit is acceptable), while the average drinking volume is constant (the 48-hour oral intake differs from the last optimization visit by less than 10% and minimum 1.0 and maximum 3.5 L per day) and average urine volume is ≥0.8 L and ≤2.5 L per day. * Willingness to adhere to an individual predefined drinking menu and urine measurements during the 48-hour fluid balance periods. * No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group, ie, CIC or stoma) from the signing of informed consent through completion of the SFU visit. * Willingness to undergo either a colonoscopy or CT/MRI colonography (if anatomically feasible and medically appropriate) and have any identified polyps removed. Exclusion Criteria: * Pregnancy and/or lactation and/or plans to become pregnant or to breastfeed. * Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to Screening Visit. Surgery for feeding tube placement and cholecystectomy allowed, after discussion with medical monitor and appropriate documentation. Any planned surgical procedures during the study duration must be discussed with the medical monitor prior to enrollment, with appropriate documentation of approval of eligibility, if applicable. * Ultra-short gut (residual length \<10 cm from duodeno-jejunal flexure). * A history of clinically significant intestinal adhesions increasing the risk of GI obstruction and/or GI contrast study(ies) of remaining small bowel suggesting subacute intestinal obstruction or mild stricture within 6 months prior to Screening. * Constipation that is not adequately managed by dietary recommendations, laxatives, or cathartic medications. * Active or untreated enterocutaneous fistula. * History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer. * Diagnosis of any variant of familial adenomatous polyposis or comparable polyposis syndrome. * Active inflammatory bowel disease or any other acute or chronic related underlying medical condition that, in the opinion of the investigator, would limit the participant's ability to complete or participate in the study, or confound study results. Discussion with the medical monitor is required. * Sepsis experienced within the previous 2 months prior to or during Screening; or a central venous catheter infection requiring the use of systemic antibiotics within 30 days prior to or during Screening, with the exception of systemic antibiotics administered for \<72 hours while awaiting the results of pending blood culture(s) that turn out negative (ie, \<72 hours empiric systemic antibiotics while ruling out a central venous catheter infection is allowed as long as the culture turns out negative). * Decompensated heart failure (New York Heart Association class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening. * Radiation enteritis, scleroderma, or residual evidence of intestinal dysmotility, including pseudo-obstruction and Hirschsprung's disease, coeliac disease, refractory or tropical sprue. * History of alcohol or drug abuse within the previous 12 months prior to Screening that, in the opinion of the investigator, could interfere with study participation, compliance, and safety of participants. * Child-Pugh scale Class C for liver disease. * Evidence of chronic renal disease as demonstrated by inadequate renal function, which is defined as estimated glomerular filtration rate \<20 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology formula). * Positive results for HIV, hepatitis A, B, and/or C tests at the Screening Visit. Note: Participants recovered from hepatitis B or C can be enrolled, ie, they have markers of the infection, but the viral load is undetectable. Participants with evidence of an acute or chronically active hepatitis B or C infection should be excluded. If a participant has a positive hepatitis A immunoglobulin M test, this would indicate an acute infection and the participant is ineligible, but they may be eligible for rescreening after recovery. Participants with positive HIV test results and undetectable viral loads may be rescreened (in case the initial test was a false positive). * Clinically significant concurrent illness (eg, uncontrolled hypertension, pancreatic or gallbladder disease) or finding on physical examination or clinical laboratory test after signing the ICF but before receiving the first dose of IMP. Note: The investigator will determine if a finding is clinically significant. The investigator will consider whether the finding 1) could prevent the participant from performing any study procedure or assessment, 2) represents a condition that would be exclusionary, 3) could represent a safety concern if the participant participated in the study, or 4) could confound any study assessment. * Elevated liver enzymes during the screening period: (a.) ALT or AST \>5 × upper limit of normal (ULN); (b.) ALT or AST \>3 × ULN and total bilirubin (TBL) \>2 × ULN or international normalized ratio (INR) \>1.5 for a person not using anticoagulant drug and INR \>3 for a person on anticoagulant therapy such as warfarin; (c.) ALT or AST \>3 × ULN and clinical signs of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia; (d.) Participants with serum conjugated bilirubin \>34 μmol/L during 2 consecutive measurements. * Use of diuretics, anti-diarrheals, and other common concomitant medications used in SBS-IF if dosing is not stable within 14 days prior to randomization. * New drug treatment other than biologic therapies, or a change to the dose or dosing interval of an existing drug treatment other than a biologic, within 1 month prior to randomization. In cases of weight loss or weight gain, dose adjustments that enable the same drug unit/kg dosing (eg, mg/kg) for weight-based dosing are permitted within 1 month prior to randomization after discussion with the medical monitor and proper documentation. * New biologic therapy or changes to dose or dosing interval of existing biologic therapy within 3 months prior to Screening, unless the dose adjustment was due to a change in weight and maintained the same drug-unit/kg (eg, mg/kg) weight-based dosing. Switching from a reference biologic product to a biosimilar, while maintaining the same dose and dosing interval, is permitted outside the 3 months prior to the screening window and/or during the study. * Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening. * At least 2 weeks of treatment with growth factors, such as growth hormone, glutamine, native GLP-2, GLP-1, short acting GLP-2 analogs (eg, teduglutide) or GLP-1 analogs within 3 months before Screening; or treatment with longer acting experimental GLP-2 analogs in the previous 6 months before Screening. Note: Prior discontinuation of GLP-2 analog treatment due to safety concerns or lack of efficacy is an exclusion criterion regardless of wash-out period. For prior discontinuation due to intolerance, the patient may be eligible based on discussion with the medical monitor. The nature of the intolerance must be clearly documented and discussed with the medical monitor. * Citrulline supplements within less than 30 days prior to Screening. * Prior use of apraglutide, or prior randomization in this study. Note: Randomization to placebo in a prior study of apraglutide is not an exclusion criterion. * Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or any apraglutide excipients. * Known antidrug antibodies (ADAs) against GLP-1 or GLP-2 analogs. * Participation in another interventional clinical study in the last 3 months before screening and during this study (studies with catheter locks or observational studies, which are not a burden on the participant and do not interfere with the participation in this study, are allowed after discussion with the medical monitor). * Incapable of understanding or unwilling to adhere to the study visit schedules and/or other protocol requirements. * Inability to prepare and/or administer the dose of the study intervention or inability to have the dose prepared and/or administered by an appropriately trained care provider. * Any condition, underlying disease, or circumstance, including psychosocial or environmental that, in the opinion of the investigator, could reduce the participant's adherence with the study visit schedule, dosing regimen, or other study requirements. * Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, study staff member, or employee of the sponsor; or the participant is a direct relative of an individual involved in the study.

Interventions

DRUG

Apraglutide

DRUG

Placebo

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Conditions

Short Bowel Syndrome (SBS)SBS Associated With Intestinal Failure (SBS-IF)

Locations

Ronald Reagan UCLA Medical Center, Center for the Health Sciences

Los Angeles, California 90095

United States

Denver Health Medical Center

Denver, Colorado 80204

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

University of Florida Health (UF Health)

Gainesville, Florida 32610

United States

GI Pros

Naples, Florida 34102

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

UofL Physicians - Colon & Rectal Surgery

Louisville, Kentucky 40202

United States

Henry Ford Medical Center - Columbus

Novi, Michigan 48377

United States

Albany Medical Center

Albany, New York 12208

United States

Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation

New York, New York 10029

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Gastro Health - Clifton

Cincinnati, Ohio 45219

United States

Cleveland Clinic - Cleveland

Cleveland, Ohio 44195

United States

OSU Wexner Medical Center

Columbus, Ohio 43210

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Buenos Aires Italian Hospital

Buenos Aires, C1199ABB

Argentina

Allende Sanatorium

Córdoba, X5000JHQ

Argentina

San Martin General La Plata Acute General Regional Hospital

La Plata, B1904CFU

Argentina

CDC Medical Center

Luján, M5505

Argentina

St Vincent's Hospital (Melbourne) Ltd

Fitzroy, VIC 3065

Australia

Austin Hospital

Heidelberg, VIC 3084

Australia

Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology

Herston, QLD 4029

Australia

Fiona Stanley Hospital, Harry Perkins Medical Research Institute

Perth, WA 6150

Australia

Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery

Linz, Upper Austria 4010

Austria

University Hospital Graz

Graz, 8010

Austria

University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology

Edegem, 2650

Belgium

University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology

Leuven, 3000

Belgium

Hospital Sao Marcos

Teresina, Piauí 64001-280

Brazil

Caxias Do Sul University / Clinical Research For Multicenter Studies Institute

Caxias do Sul, Rio Grande do Sul 95070-560

Brazil

Porto Alegre Clinical Hospital (HCPA)

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Regional Medical School Foundation (CIP HB/FAMERP)

São José do Rio Preto, São Paulo 15090-000

Brazil

QualiVida Higienopolis - Hapvida NotreDame

São Paulo, São Paulo 01233-000

Brazil

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, São Paulo 05403-000

Brazil

Pacific Gastroenterology Associates

Vancouver, British Columbia V6Z 2K5

Canada

CHUM - University of Montreal Hospital Centre

Montreal, Quebec H2X 3E4

Canada

University Hospital Brno, Clinic of Internal Medicine - Gastroenterology

Brno, 625 00

Czechia

University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic

Hradec Králové, 500 05

Czechia

University Hospital Kralovske Vinohrady, Internal Clinic

Prague, 100 00

Czechia

General University Hospital in Prague

Prague, 128 08

Czechia

Rigshospitalet - University Hospital Copenhagen

Copenhagen, DK-2100

Denmark

Beaujon Hospital - APHP

Clichy, 92110

France

Hospices Civils de Lyon - Lyon Sud

Lyon, 69310

France

Nantes University Hospital Center - Hotel Dieu Hospital

Nantes, 44000

France

Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital

Pessac, 33600

France

Nancy Regional University Hospital Center - Brabois Hospital

Vandœuvre-lès-Nancy, 54500

France

University Hospital Heidelberg, Department of Endocrinology and Metabolism

Heidelberg, Baden-Wurttemberg 69120

Germany

University Hospital Erlangen

Erlangen, Bavaria 91054

Germany

Asklepios Clinic St. Georg

Hamburg, Free and Hanseatic City of Hamburg 20099

Germany

University Hospital Bonn

Bonn, North Rhine-Westphalia 53127

Germany

University Duisburg-Essen, University Hospital Essen

Essen, North Rhine-Westphalia 45147

Germany

University Hospital Muenster

Münster, North Rhine-Westphalia 48149

Germany

University Hospital Aachen AoeR

Aachen, Rhine-Westphalia 52074

Germany

Charite - University Hospital Berlin

Berlin, State of Berlin 10117

Germany

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, H-1082

Hungary

University of Szeged, Department of Internal Medicine- Western Site

Szeged, H-6725

Hungary

Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic

Haifa, 3109601

Israel

Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic

Jerusalem, 9103102

Israel

Meir Medical Center, Institute of Gastroenterology and Liver Diseases

Kfar Saba, 4428164

Israel

The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic

Tel Aviv, 64239

Israel

Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit

Tel Litwinsky, 5262000

Israel

Polyclinic San Matteo, IRCCS

Pavia, Lombardy 27100

Italy

University Hospital of Padova

Padova, Veneto 35128

Italy

IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi

Bologna, 40138

Italy

Careggi University Hospital

Florence, 50134

Italy

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

Milan, 20122

Italy

University Hospital City of Health and Science of Turin - Hospital Molinette

Torino, 10126

Italy

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa 221-0855

Japan

Saga-Ken Medical Centre Koseikan

Saga, Saga-ken 840-8571

Japan

Kagawa University Hospital

Kagawa, 761-0793

Japan

Radboud University Medical Center (Radboudumc)

Nijmegen, 6525GA

Netherlands

Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care

Bydgoszcz, 85-391

Poland

Medrise Sp. z o.o. (LLC)

Lublin, 20-582

Poland

Jerzy Gromkowski Provincial Specialist Hospital

Wroclaw, 51-149

Poland

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591

South Korea

University Hospital Virgen del Rocio (HUVR)

Seville, Andalusia 41013

Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377

Taiwan

Far Eastern Memorial Hospital

New Taipei City, 220

Taiwan

Taichung Veterans General Hospital

Taichung, 407219

Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, 10330

Thailand

Phramongkutklao Hospital

Bangkok, 10400

Thailand

Ramathibodi Hospital

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Songklanagarind Hospital

Hat Yai, 90110

Thailand

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, 30000

Thailand

St Mark's Hospital

London, Middlesex HA1 3UJ

United Kingdom

Aberdeen Royal Infirmary

Aberdeen, Scotland AB25 2ZN

United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH

United Kingdom

Royal London Hospital

London, E1 1FR

United Kingdom

Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit

Salford, M6 8HD

United Kingdom